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Takeda Canada Inc. v. Canada (Minister of Health)

In Takeda Canada Inc. v. Canada (Minister of Health), 2015 FC 751, the Federal Court dismissed an application brought by Takeda Canada Inc. and Takeda GMBH under the Patented Medicines (Notice of Compliance) Regulations (the Regulations) in relation to the drug TECTA (pantoprazole magnesium). Takeda was seeking to prohibit the Minister of Health from issuing market authorization to Mylan Pharmaceuticals ULC for its generic pantoprazole magnesium drug until the expiry of Canadian Patent No. 2,341,031 (the 031 Patent). Pantoprazole magnesium is used to treat ulcers and other gastro-esophageal conditions.

This is the first patent decision relating to pantoprazole magnesium and is a rare instance of a Canadian court holding a patent invalid for inherent anticipation.

This decision allowed Mylan to immediately receive market authorization and become the first generic company to sell its lower cost pantoprazole magnesium product in Canada.

The principal claim in issue was directed to pantoprazole magnesium dihydrate, a solid form of the drug incorporating two molecules of water for every molecule of pantoprazole magnesium in a crystalline structure. The Court held that Mylan’s allegations that the relevant claim was not infringed and invalid for anticipation were justified.

With respect to anticipation, the Court held that a prior patent application inherently anticipated the claim at issue in the 031 Patent by disclosing a process that produced the alleged invention, pantoprazole magnesium dihydrate. The Court relied upon an experiment conducted by a Mylan expert demonstrating that a method disclosed in the prior art application produced pantoprazole magnesium dihydrate. Even though the prior application did not expressly disclose that pantoprazole magnesium dihydrate was made, the Court concluded that the prior application anticipated the alleged invention because a skilled person following the prior art method would inevitably or necessarily have obtained the invention.

The Court rejected Takeda’s criticisms of the Mylan experiment as theoretical and unsupported.

With respect to non-infringement, the Court found that Mylan did not infringe the 031 Patent because its proposed pantoprazole magnesium drug product was in a different crystalline form than a dihydrate. Again, the Court preferred and relied upon the opinion of Mylan’s experts that its proposed product had a different x-ray powder diffraction (XRPD) fingerprint than the alleged invention disclosed in the 031 Patent.